Medidenta ME-E4R
by Medidenta
Medidenta ME-E4R is a Class I device made by Medidenta, cleared under FDA 510(k) K030603 on 14 Apr 2003 and listed in FDA GUDID since 30 Dec 2022 (UDI-DI 00850046903182), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850046903182 | Date30 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK030603 | Date14 Apr 2003 | StatusActive |
Official records
- AccessGUDID record 00850046903182
- FDA 510(k) database K030603
Across registries
- FDA 510(k) K030603 decided 14 Apr 2003 Active
- FDA GUDID UDI-DI 00850046903182 listed 30 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K030603
- Listed FDA GUDID 00850046903182
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Medidenta
- Generic name
- Dental surgical power tool motorized handpiece/set, electric
- Model / Ref / Catalog
- ME-E4R
- Primary DI / UDI-DI
- 00850046903182
- 510(k) Number
- FDA product code
- EGS
- GMDN term
- Dental surgical power tool motorized handpiece/set, electric
- Device class
- Class I
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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